Senior Systems Engineer
Siemens HealthineersAbout the role
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.
Siemens Healthineers is seeking a highly motivated and detail-oriented Senior Systems Engineer to join our Ultrasound R&D team in Issaquah, WA. In this role, you will contribute to the development and lifecycle management of ultrasound systems and non-product software tools. You’ll be responsible for leading system engineering activities including risk management, requirements analysis, validation planning, and cross-functional coordination to ensure safe, effective, and regulatory-compliant products and solutions.
You are responsible for:
Leading and facilitating cross-functional team meetings to track project milestones, identify risks, resolve roadblocks, and maintain project alignment across engineering, quality, and regulatory functions.
Conducting and maintaining risk management activities throughout the product lifecycle, including initial hazard analysis, mitigation strategy development, and risk portfolio tracking.
Collaborating in system and subsystem requirements review and validation activities, ensuring alignment with design inputs and intended use.
Leading validation efforts for non-product software tools, including risk-based validation planning, protocol development, execution oversight, and quality documentation.
Supporting CAPA remediation and sustaining engineering efforts by developing corrective strategies within requirement management systems.
Contributing hands-on in lab environments to investigate product behavior, troubleshoot technical issues, and verify design functionality.
Developing and maintaining quality documentation, including work instructions and validation plans, ensuring compliance with regulatory standards.
Minimum Qualifications:
Bachelor’s or Master’s degree in Engineering, Biomedical Engineering, or related field.
5+ years of experience in systems engineering or related roles within the medical device industry.
Working knowledge of FDA guidelines, ISO 13485, IEC 60601, and relevant quality management and safety standards.
Experience with risk management, requirements engineering, and non-product software validation.
Strong problem-solving, decision-making, and systems-thinking capabilities.
Excellent interpersonal and communication skills for effective cross-functional collaboration.
Ability to lead without authority, drive consensus, and maintain a focus on both technical detail and high-level objectives.
Preferred Qualifications:
Experience with ultrasound systems or medical imaging technologies.
Familiarity with tools such as DOORS, Jira, or Polarion.
Exposure to Agile/Kanban development environments.
Who we are: We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
To find out more about Siemens Healthineers businesses, please visit our company page here.
The annual base pay for this position is:
Min $133,900 - Max $200,900Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.
If this is a commission eligible position the commission eligibility will be in accordance with the terms of the
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